Catheter-associated urinary tract infections (CAUTI) are the most common hospital- acquired infections, accounting for over one million cases and hospital costs of more than $500 million each year in the U.S. alone. Recent reimbursement changes from the Centers of Medicare and Medicaid Services will place this cost burden directly onto hospitals, creating an immediate incentive to address this neglected aspect of care. The current paradigm for preventing bacterial UTIs has been to introduce antimicrobial agents to reduce the occurrence of bacteriuria. However, antimicrobial agents produce resistance patterns that make indwelling catheter infections more difficult to treat. No antimicrobial catheter now on the market has been endorsed by either CDC/APIC due to a lack of clinically relevant supporting data. Sharklet Technologies therefore proposes to further develop a novel Foley catheter design that inhibits bacterial colonization and that does not rely on traditional antibiotic coatings or treatments. Our Phase I SBIR work proved the feasibility of using the novel Sharklet" micro-pattern polymer surface to inhibit bacterial biofilm growth-setting the stage for a larger Phase II project designed to fully prototype and demonstrate the potential for the Sharklet technology. The overall goal of this multi-phase SBIR project is to commercialize a silicone Foley catheter with the Sharklet micro-pattern that will reduce CAUTI. During Phase I the Sharklet R&D team demonstrated this new concept by reducing colonization of uropathogenic Escherichia coli with in vitro via testing of three Sharklet micro-patterns relative to a smooth surface and by successfully fabricating silicone tube prototypes with the Sharklet pattern on the extraluminal and intraluminal surfaces. Based on that success, Phase II work will focus on the following three Aims: First, to extend in vitro efficacy testing to three additional, relevant uropathogens and to test inhibition of bacterial migration in an in vitro bladder model. Second, Sharklet-patterned Foley catheters will be manufactured via our OEM partner, Medical Components Inc. The manufactured catheters will undergo standard testing to ensure they meet FDA criteria for biocompatibility and functional performance, as well as repeated in vitro bladder model testing to obtain device claims for the FDA 510(k) submission that will be made at the end of Phase II. Third, Phase II will conclude with a pilot clinical study to evaluate the ability of the Sharklet-patterned Foley catheter to inhibit bacterial migration on the catheter surface. This study will be an integral precursor to a statistically powered clinical trial for confirming the Sharklet Foley catheter's ability to reduce CAUTI. Phase II success will set the stage for providing a much-needed tool for clinicians/hospitals to improve patient care and reap significant cost savings with the reduced burden of infection enabled by the Sharklet Foley catheter. The Phase II data is critical for engaging the "Phase III" investors/industry partners needed to complete the required development/approval work and to ultimately commercialize this new technology. PUBLIC HEALTH RELEVANCE: Catheter-associated urinary tract infections (CAUTI) are the most common hospital- acquired infections, resulting in significant patient setbacks, discomfort, and medical costs of over half a billion dollars annually in the U.S. alone. With its successful Phase I SBIR work, Sharklet Technologies proved the feasibility of its new Sharklet" micro-pattern concept (based on shark skin) for Foley catheter manufacture that inhibits bacterial colonization without the use of antimicrobial coatings or treatments. The Sharklet team now proposes a Phase II project to fully prototype and demonstrate efficacy of the Sharklet Foley catheter in preparation for the FDA clearance required to ultimately commercialize a new product that will substantially reduce the occurrence of CAUTI.